Morning! A few of you have been asking what trials are available if you find yourself Covid-19 positive again. This happened to me in November 2021, likely delta, after two vaccinations with Astra Zeneca. It's likely that my antibodies, if I ever made any, were waning and it was before I felt ready to consider a Pfizer booster due to a profound relapse in my cognitive dysfunction for 6 weeks after each vaccine. Obviously as a long hauler having acute Covid-19 again is a very scary prospect.
After consulting with the members of the Facebook group Covid-19 Research Involvement Group I found out about three trials going on in the UK:
The PRINCIPLE trial - a UK -wide clinical study from the University of Oxford to find COVID-19 treatments for recovery at home.
The COVID 201 Study - assessing testing the effect of a study drug on people with COVID-19. The drug is administered as nasal drops - COVIDROPS. These will be compared to placebo nasal drops.
The PANORAMIC trial - also run by the University of Oxford in close collaboration with GP hubs. The government is urging everyone aged 50 and over, or between 18 to 49 with an underlying health condition, to sign up to the trial if they test positive for COVID-19. This trial uses Molnupiravir another antiviral drug.
1. The PRINCIPLE Trial
This trial is looking for medicines that can help people with COVID-19 get better quickly and stop them needing to go into hospital. They have so far recruited over 8000 participants through their website and GP practices. It is open to all with ongoing ACUTE COVID-19 symptoms regardless of vaccine status.
You are eligible if:
You are currently experiencing COVID-19 symptoms for 14 days or less
AND: You have had a positive PCR test for COVID-19 in the past 14 days (this may prove difficult currently)
AND: You are aged 18 and over
Originally the trial was to look at comparing:
Favipiravir (an anti-viral drug)
The usual standard of NHS care.
There has been a press release to say that the Ivermectin arm of the trial has been dropped as the trial team has been unable to source Ivermectin due to worldwide demand!
I entered the trial in November and to my disappointment was assigned to "the usual standard of NHS care". I had to fill in a daily dairy of symptoms and whether I had needed to see a GP, go to hospital etc for 28 days. Very simple to do with daily reminders and a £20 Amazon voucher at the end for your efforts.
2. The Covid 201 Study
The COVID 201 Study is looking at the drug COVIDROPS which are a neutralising antibody. The aim is to see if the treatment can reduce the viral load (the amount of virus in the body) 8 days after the treatment is given. It is also looking at how safe the treatment is.
You are eligible if:
You are 18 years old or older
AND: You have tested positive for COVID-19 (PCR) within the last 4 days
AND: You have mild or no symptoms
- Mild symptoms include fever, cough, sore throat, headache, muscle pain, nausea, vomiting, diarrhoea and loss of taste or smell.
This study is more involved and you will need to be able to take part for up to 72 days, have 3-4 nurse visits which can last 4 hours, 3 phone calls, ECGs, blood and urine samples, medical questionnaires, pregnancy test, PCR testing, a daily diary for 5 weeks. For this you are compensated £250.
I also enrolled for this one, with the proviso that I would drop out of whichever study I did not receive medication/ placebo.
I got as far as the initial nurse visit which lasted a few hours but she repeated my PCR nasal swab which proved to be negative so I could not be accepted for the study. (It was about a week after my initial positive PCR test).
I was eligible for a part payment of £50. (I have not received this).
3. The PANORAMIC Trial
The PANORAMIC trial involves Molnupiravir which has shown in clinical trials to reduce the risk of hospitalisation or death for at-risk, non-hospitalised adults with mild to moderate COVID-19 by 30%. This will be compared to usual standard NHS care. This trial has currently recruited around 2500 participants.
You are eligible if:
You are currently experiencing COVID-19 symptoms beginning in the last 5 days.
AND: You have had a positive PCR test OR LATERAL FLOW for COVID-19
AND: You are aged 50 or over
OR: Aged 18 or over with a LISTED preexisting condition as follows:
Please note Molnupiravir has potential downsides. It works by introducing mutations in virus DNA, so anyone pregnant or breastfeeding cannot take it in case it harms their fetus or baby. Participants capable of getting pregnant will be sent a pregnancy test and must use contraception.
Taking part in the study will involve answering a few questions online each day for 28 days through the PANORAMIC website, or receive a phone call from the trial team on days 7, 14 and 28 to speak about your symptoms.
The trial team will also contact you at 3 and 6 months after you started the trial, where we will ask you about ant long-term COVID-19 symptoms.
You may withdraw from the trial at any stage by simply contacting the trial team.
Important to note:
Those people with cancer, people with Down’s syndrome or those with very weak immune systems are eligible for specialist treatment: About 70 hospital clinics called Covid Medicines Delivery Units have been set up around the UK to help these groups. The main treatment on offer is an intravenous therapy called sotrovimab, an artificial antibody designed to block the coronavirus. Sotrovimab maintains enough efficacy to be useful against Omicron.
The PRINCIPLE trial may take on PAXLOID another antiviral oral pill which may reduce the risk of developing severe covid-19 by nearly 90 per cent. Paxlovid consists of a drug that blocks an enzyme the coronavirus needs to reproduce – a similar mechanism to some anti-HIV drugs – as well as another compound that slows the drug’s breakdown. Paxlovid is currently under review for approval in the UK. It has just been granted emergency approval in the USA.
So there is my research into trials/ studies available to people who are testing positive for COVID-19 for the first, second, third time regardless of vaccine status. My advice is too get in early preferably on the day you test positive.
The PRINCIPLE trial https://www.principletrial.org
Article about postponement of Ivermectin arm https://www.medpagetoday.com/special-reports/exclusives/96194
The COVID 201 study https://covid201.com/COVID201
The PANORAMIC trial https://www.panoramictrial.org
COVID-19 Research Involvement Group https://www.facebook.com/groups/2590602557864509